Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00097071
First received: November 17, 2004
Last updated: June 15, 2012
Last verified: June 2012

November 17, 2004
June 15, 2012
October 2004
May 2006   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: After 16 weeks treatment ] [ Designated as safety issue: No ]
Safety of NovoLog in children using Insulin pumps
Complete list of historical versions of study NCT00097071 on ClinicalTrials.gov Archive Site
Measurements of glycaemic control, safety parameters including frequency of hypoglycaemia, laboratory tests, clinical evaluations and adverse events [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents
Safety and Efficacy of Insulin Aspart Versus Insulin Lispro in Insulin Pumps in Children and Adolescents With Type 1 Diabetes

This trial is conducted in the United States of America (USA). It is demonstrated that intensive insulin therapy resulting in good glycaemic control can reduce or delay the incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin injection (CSII) therapy in the pediatric and adolescent age population. This trial compares the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered by CSII in children and adolescents with type 1 diabetes.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: insulin lispro
  • Drug: insulin aspart
Not Provided
Weinzimer SA, Ternand C, Howard C, Chang CT, Becker DJ, Laffel LM; Insulin Aspart Pediatric Pump Study Group. A randomized trial comparing continuous subcutaneous insulin infusion of insulin aspart versus insulin lispro in children and adolescents with type 1 diabetes. Diabetes Care. 2008 Feb;31(2):210-5. Epub 2007 Nov 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
299
May 2006
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 Diabetes
Both
3 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00097071
ANA-2181
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Campbell Howard, MD Novo Nordisk A/S
Novo Nordisk A/S
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP